Thelin ( DrugBank: - )


1 disease
IDDisease name (Link within this page)Number of trials
86Pulmonary arterial hypertension12

86. Pulmonary arterial hypertension


Clinical trials : 1,181 Drugs : 701 - (DrugBank : 126) / Drug target genes : 105 - Drug target pathways : 192
No.TrialIDDate_
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PhaseCountries
1NCT00995566
(ClinicalTrials.gov)
April 201017/9/2009A Non-Interventional, Patient Registry For The Collection Of Pre-Defined Safety Data In Patients Prescribed ThelinThelin (Sitaxentan Sodium) Patient Safety Registry A Non-Interventional, Patient Registry For The Collection Of Pre-Defined Safety Data In Patients Prescribed ThelinPulmonary Arterial HypertensionDrug: Sitaxentan sodiumPfizerNULLTerminated18 YearsN/AAll54N/ABelgium;France;Germany;Sweden
2EUCTR2008-005885-30-CZ
(EUCTR)
12/01/201010/12/2008A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,SAFETY AND EFFICACY STUDY OF SITAXSENTAN SODIUM IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSIONA PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,SAFETY AND EFFICACY STUDY OF SITAXSENTAN SODIUM IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION Pulmonary arterial hypertension
MedDRA version: 9.1;Level: HLT;Classification code 10037401;Term: Pulmonary hypertensions
Trade Name: Thelin
INN or Proposed INN: SITAXSENTAN SODIUM
Pfizer LtdNULLNot RecruitingFemale: yes
Male: yes
150Phase 3Czech Republic;Bulgaria
3EUCTR2008-005887-14-CZ
(EUCTR)
12/01/201010/12/2008A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, EFFICACY AND SAFETY STUDY OF MONOTHERAPY SITAXSENTAN SODIUM VERSUS COMBINATION THERAPY WITH SITAXSENTAN SODIUM AND SILDENAFIL CITRATE IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION WHO HAVE COMPLETED STUDY B1321001A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, EFFICACY AND SAFETY STUDY OF MONOTHERAPY SITAXSENTAN SODIUM VERSUS COMBINATION THERAPY WITH SITAXSENTAN SODIUM AND SILDENAFIL CITRATE IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION WHO HAVE COMPLETED STUDY B1321001 Pulmonary Arterial Hypertension
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Trade Name: Thelin
INN or Proposed INN: Sitaxsentan Sodium
Trade Name: Revatio
INN or Proposed INN: Sildenafil Citrate
Pfizer Ltd.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3Czech Republic;Bulgaria
4EUCTR2008-005886-78-CZ
(EUCTR)
12/01/201010/12/2008A PHASE 3, MULTI-CENTER, OPEN LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY OF MONOTHERAPY SITAXSENTAN SODIUM AND COMBINATION THERAPY WITH SITAXSENTAN SODIUM AND SILDENAFIL CITRATE IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSIONA PHASE 3, MULTI-CENTER, OPEN LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY OF MONOTHERAPY SITAXSENTAN SODIUM AND COMBINATION THERAPY WITH SITAXSENTAN SODIUM AND SILDENAFIL CITRATE IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION PULMONARY ARTERIAL HYPERTENSION
MedDRA version: 9.1;Level: HLT;Classification code 10037401;Term: Pulmonary hypertensions
Trade Name: Thelin
INN or Proposed INN: Sitaxsentan Sodium
Trade Name: Revatio
INN or Proposed INN: Sildenafil citrate
Pfizer Ltd.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3Czech Republic;Bulgaria
5NCT01445873
(ClinicalTrials.gov)
December 1, 200930/9/2011Pilot Chart Review Study Of Sitaxentan Sodium (Thelin) In Patients With Pulmonary Arterial Hypertension (PAH)NON-INTERVENTIONAL (NI) DRUG STUDY PROTOCOL: THREE-COUNTRY PILOT STUDY FOR RETROSPECTIVE CHART REVIEW OF EFFECTIVENESS OF THELIN® (SITAXSENTAN) IN PATIENTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH)Pulmonary Arterial HypertensionDrug: Sitaxentan sodiumPfizerNULLCompleted18 YearsN/AAll36NULL
6EUCTR2008-005886-78-BG
(EUCTR)
25/06/200919/06/2009A PHASE 3, MULTI-CENTER, OPEN LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY OF MONOTHERAPY SITAXSENTAN SODIUM AND COMBINATION THERAPY WITH SITAXSENTAN SODIUM AND SILDENAFIL CITRATE IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSIONA PHASE 3, MULTI-CENTER, OPEN LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY OF MONOTHERAPY SITAXSENTAN SODIUM AND COMBINATION THERAPY WITH SITAXSENTAN SODIUM AND SILDENAFIL CITRATE IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION PULMONARY ARTERIAL HYPERTENSION
MedDRA version: 9.1;Level: HLT;Classification code 10037401;Term: Pulmonary hypertensions
Trade Name: Thelin
INN or Proposed INN: Sitaxsentan Sodium
Trade Name: Revatio
INN or Proposed INN: Sildenafil citrate
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
150Phase 3Czech Republic;Bulgaria
7EUCTR2008-005887-14-BG
(EUCTR)
25/06/200919/06/2009A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, EFFICACY AND SAFETY STUDY OF MONOTHERAPY SITAXSENTAN SODIUM VERSUS COMBINATION THERAPY WITH SITAXSENTAN SODIUM AND SILDENAFIL CITRATE IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION WHO HAVE COMPLETED STUDY B1321001A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, EFFICACY AND SAFETY STUDY OF MONOTHERAPY SITAXSENTAN SODIUM VERSUS COMBINATION THERAPY WITH SITAXSENTAN SODIUM AND SILDENAFIL CITRATE IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION WHO HAVE COMPLETED STUDY B1321001 Pulmonary Arterial Hypertension
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Trade Name: Thelin
INN or Proposed INN: Sitaxsentan Sodium
Trade Name: Revatio
INN or Proposed INN: Sildenafil Citrate
Pfizer Limited, Ramsgate Road, Sandwich, Kent, UKNULLNot RecruitingFemale: yes
Male: yes
150Phase 3Czech Republic;Bulgaria
8EUCTR2008-005885-30-BG
(EUCTR)
25/06/200919/06/2009A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,SAFETY AND EFFICACY STUDY OF SITAXSENTAN SODIUM IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSIONA PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,SAFETY AND EFFICACY STUDY OF SITAXSENTAN SODIUM IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION Pulmonary arterial hypertension
MedDRA version: 13.1;Level: HLT;Classification code 10037401;Term: Pulmonary hypertensions;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Trade Name: Thelin
INN or Proposed INN: SITAXSENTAN SODIUM
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
150Phase 3Czech Republic;Bulgaria
9EUCTR2008-005885-30-SK
(EUCTR)
06/04/200920/02/2009A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,SAFETY AND EFFICACY STUDY OF SITAXSENTAN SODIUM IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSIONA PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,SAFETY AND EFFICACY STUDY OF SITAXSENTAN SODIUM IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION Pulmonary arterial hypertension
MedDRA version: 9.1;Level: HLT;Classification code 10037401;Term: Pulmonary hypertensions
Trade Name: Thelin
INN or Proposed INN: SITAXSENTAN SODIUM
Pfizer LimitedNULLNot RecruitingFemale: yes
Male: yes
150Phase 3Czech Republic;Slovakia;Bulgaria
10EUCTR2008-005886-78-SK
(EUCTR)
06/04/200920/02/2009A PHASE 3, MULTI-CENTER, OPEN LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY OF MONOTHERAPY SITAXSENTAN SODIUM AND COMBINATION THERAPY WITH SITAXSENTAN SODIUM AND SILDENAFIL CITRATE IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSIONA PHASE 3, MULTI-CENTER, OPEN LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY OF MONOTHERAPY SITAXSENTAN SODIUM AND COMBINATION THERAPY WITH SITAXSENTAN SODIUM AND SILDENAFIL CITRATE IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION PULMONARY ARTERIAL HYPERTENSION
MedDRA version: 9.1;Level: HLT;Classification code 10037401;Term: Pulmonary hypertensions
Trade Name: Thelin
INN or Proposed INN: Sitaxsentan Sodium
Trade Name: Revatio
INN or Proposed INN: Sildenafil citrate
Pfizer Limited, Ramsgate Road, Sandwich, Kent UKNULLNot RecruitingFemale: yes
Male: yes
150Phase 3Czech Republic;Slovakia;Bulgaria
11EUCTR2008-005887-14-SK
(EUCTR)
01/04/200920/02/2009A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, EFFICACY AND SAFETY STUDY OF MONOTHERAPY SITAXSENTAN SODIUM VERSUS COMBINATION THERAPY WITH SITAXSENTAN SODIUM AND SILDENAFIL CITRATE IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION WHO HAVE COMPLETED STUDY B1321001A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, EFFICACY AND SAFETY STUDY OF MONOTHERAPY SITAXSENTAN SODIUM VERSUS COMBINATION THERAPY WITH SITAXSENTAN SODIUM AND SILDENAFIL CITRATE IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION WHO HAVE COMPLETED STUDY B1321001 Pulmonary Arterial Hypertension
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Trade Name: Thelin
INN or Proposed INN: Sitaxsentan Sodium
Trade Name: Revatio
INN or Proposed INN: Sildenafil Citrate
Pfizer Limited, Ramsgate Road, Sandwich, Kent, UKNULLNot RecruitingFemale: yes
Male: yes
150Phase 3Czech Republic;Slovakia;Bulgaria
12NCT00080457
(ClinicalTrials.gov)
May 20031/4/2004Safety and Efficacy Study of Sitaxentan Sodium (Thelin™) in Patients With Pulmonary Arterial HypertensionA Phase 3, Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Sitaxsentan Sodium (Thelin™) Treatment With an Open-Label Bosentan Arm in Patients With Pulmonary Arterial Hypertension (PAH)Pulmonary HypertensionDrug: sitaxsentan sodiumEncysive PharmaceuticalsNULLCompleted12 Years75 YearsBoth240Phase 3United States